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Applications for Changes of the Labelling or PIL Not Associated with SmPC (Type P Variations) - 7%
29.08.2022 10:31:34SÚKL informs marketing authorisation holders (MAH) about the aspects of submitting applications for changes of the labelling or PIL not associated with the SmPC (Notification under Article 61(3) of Directive 2001/83/EC and under Section 35(5) of the Act on Pharmaceuticals; so called Type P variations), incl. procedural differences between national and MRP variations and how to distinguish between them in specific cases.
Applications for Transfers of Marketing Authorisations of Medicinal Products - 6%
25.08.2022 09:05:15SÚKL informs marketing authorisation holders about the aspects of submitting applications for transfers of the medicinal product marketing authorisations, including information on differences between marketing authorisation transfers effective as of the date when the decisions on the marketing authorisation transfers come into force or as of a future date. The provided information applies to medicinal products authorised via national procedures as well as MRP/DCP.
Scientific Advice on Marketing Authorisation Issues - 6%
24.05.2022 13:40:00Upon request, the Marketing Authorisation Section of the State Institute for Drug Control (hereinafter referred to as the “Institute”) provides Scientific Advice concerning procedural-regulatory issues and scientific requirements associated, in particular, with applications for marketing authorisation and applications for variations to and renewals of marketing authorisation. Scientific Advice is a paid service of the Institute and it is provided only beyond the scope of ongoing administrative procedures (e.g., prior to the submission of a marketing authorisation application in the phase of “medicinal product development”, prior to the submission of an application for variation to or renewal of marketing authorisation).
Information for academia - 6%
30.09.2022 14:19:54EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
Obligations Applicable to Holders of Centralised Marketing Authorisations - 6%
10.05.2013 14:36:40Obligations applicable to Marketing Authorisation Holders of Products Authorised via the Centralised Procedure in relation to State Institute for Drug Control.
Procedure for the Submission of Applications for Mutual Recognition of Marketing Authorisations with the Czech Republic Acting as the RMS - 6%
26.08.2019 09:54:20SÚKL hereby specifies the requirements governing the submission of applications for marketing authorisation mutual recognition procedures with the Czech Republic acting as the RMS (so called MRP/RUP-RMS).
DCP Slots Allocation with SÚKL as the RMS - 6%
4.12.2017 13:52:23SÚKL informs about a system of slots allocation within the scope of decentralised procedures (DCP) with SÚKL as the Reference Member State (RMS), effective as of 1 January 2018. DCP slots are allocated on a continuous basis for each half of a month.
Questions and answers on the amended Act on Pharmaceuticals - marketing authorisations - 6%
5.04.2013 13:09:54The amended Act on Pharmaceuticals came into effect on 2 April 2013. We would like to summarize the major changes concerning marketing authorisations, pharmacovigilance and clinical trials, in the form of questions and answers.
KLH-20 version 6 - 6%
7.01.2021 10:51:58This guideline supersedes guideline KLH-20 version 5 as of 10 April 2020.
Information on the EU Synchronisation of PSUR submission - 6%
11.04.2007 14:59:07SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures.
Questions and answers on the amended Act on Pharmaceuticals - clinical trials - 6%
8.04.2013 09:54:32The amended Act on Pharmaceuticals came into effect on 2 April 2013. We would like to summarize the major changes concerning marketing authorisations, pharmacovigilance and clinical trials, in the form of questions and answers.
SUKL Bulletin - 5%
19.11.2007 10:24:33SUKL Bulletin has been published on a monthly basis by the State Institute for Drug Control in cooperation with Prof. Skarnitzl’s Foundation since 1994. It provides information on pharmaceuticals and on medical devices to healthcare professionals and pursuant to Act No 79/1997 Coll., on Pharmaceuticals, as amended, serves for the publication of issued decisions on marketing authorisations of medicinal products.
REG-59 version 1 - 5%
28.01.2009 11:23:15Requirements for marketing authorisations of medicinal products in respect of risk of transmitting animal spongiform encephalopathy agents
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